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- Title
Phase I/II trial of biweekly docetaxel and cisplatin with concurrent thoracic radiation for stage III non-small-cell lung cancer.
- Authors
Iwasaki, Yoshinobu; Ohsugi, Shuji; Natsuhara, Atsushi; Tsubokura, Takuji; Harada, Hidehiko; Ueda, Mikio; Arimoto, Taichiro; Hara, Hiroshi; Yamada, Tadaaki; Takesako, Toshiyuki; Kohno, Kenji; Hosogi, Shigekuni; Nakanishi, Masaki; Marunaka, Yoshinori; Nishimura, Tsunehiko
- Abstract
Objectives: We conducted phase I and II studies of biweekly docetaxel and cisplatin with concurrent radiotherapy, followed by consolidation chemotherapy with the same drugs in patients with locally advanced, unresectable non-small-cell lung cancer (NSCLC). Our objectives were to define the maximum-tolerated dose and dose-limiting toxicity (DLT) in the phase I study, and to determine the response rate, toxicity, and survival rate at the recommended dose (RD) in the phase II study. Methods: Patients with unresectable stage IIIA and IIIB NSCLC were studied. Six to eight cycles of docetaxel and cisplatin were administered at 2-week intervals. In the phase I study, patients received four dose levels: level 1, docetaxel/cisplatin=30/40 mg/m2; level 2, 35/40; level 3, 40/40; and level 4, 45/40. Radiotherapy was delivered at a rate of 2 Gy per fraction/day up to a total dose of 60 Gy over the course of 6 weeks, during the first three cycles of chemotherapy. Results: DLT comprised neutropenia at level 4 in the phase I study ( n=15), and level 3 was considered the RD. In the phase II study ( n=46), two patients had a complete response (4.3%) and 34 had a partial response (73.9%), for an overall response rate of 78.2% [95% CI (66.3–90.2%)]. The survival rate was 69.1% at 1 year and 39.6% at 2 years, with a median survival time of 19.1 months. Leukopenia, neutropenia, anemia, and radiation esophagitis were the most common toxic reactions, with Grade ≥3 reactions occurring at rates of 77, 70, 17, and 8%, respectively. Conclusion: Biweekly docetaxel and cisplatin with concurrent RT was active and well tolerated in patients with unresectable stage III NSCLC.
- Subjects
DOCETAXEL; ANTINEOPLASTIC agents; CISPLATIN; DRUG therapy; LUNG cancer; NEUTROPENIA
- Publication
Cancer Chemotherapy & Pharmacology, 2006, Vol 58, Issue 6, p735
- ISSN
0344-5704
- Publication type
Article
- DOI
10.1007/s00280-006-0220-y